Dermal Cooling Pack/Vacuum/Massager
The Dermal Cooling Pack/Vacuum/Massager (product code OOK) is a Class 2 surgical device regulated under 21 CFR 878.4340 in the General, Plastic Surgery specialty (SU), cleared via 510(k). It is a combination device incorporating a cooling pad with a vacuum or mechanical massager intended to disrupt or induce changes in adipocyte cells for body contouring or circumference reduction. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OOK
- Device Class
- FDA class 2
- Regulation Number
- 878.4340
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
The device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption or induction of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233732 | CoolSculpting Elite System | Sep 12, 2024 | Substantially Equivalent | Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics |
| K212707 | CoolSculpting Elite System | Nov 05, 2021 | Substantially Equivalent | Zeltiq Aesthetics, Inc. |
| K193566 | ZELTIQ CoolSculpting System | Jan 21, 2020 | Substantially Equivalent | Zeltiq Aesthetics, Inc. |
| K183514 | ZELTIQ CoolSculpting System | Jan 14, 2019 | Substantially Equivalent | Zeltiq Aesthetics, Inc. |
| K181740 | ZELTIQ CoolSculpting System | Aug 29, 2018 | Substantially Equivalent | Zeltiq Aesthetics, Inc. |
| K172144 | CoolSculpting System | Nov 01, 2017 | Substantially Equivalent | Zeltiq Aesthetics |
| K171069 | ZELTIQ CoolSculpting System | Jul 07, 2017 | Substantially Equivalent | Zeltiq Aesthetics, Inc. |
| K162050 | ZELTIQ CoolSculpting System | Nov 21, 2016 | Substantially Equivalent | Zeltiq Aesthetics, Inc. |
| K160259 | ZELTIQ CoolSculpting System | Mar 23, 2016 | Substantially Equivalent | Zeltiq Aesthetics, Inc. |
| K151179 | ZELTIQ CoolSculpting System | Sep 22, 2015 | Substantially Equivalent | Zeltiq Aesthetics, Inc. |
| K142491 | ZEL TIQ CoolSculpting System | Jan 26, 2015 | Substantially Equivalent | Zeltiq Aesthetics, Inc. |
| K133212 | ZELTIQ COOLSCULPTING SYSTEM | Apr 09, 2014 | Substantially Equivalent | Zeltiq Aesthetics, Inc. |
| K120023 | ZELTIQ COOLSCULPTING | May 02, 2012 | Substantially Equivalent | Zeltiq Aesthetics, Inc. |
| DEN090002 | ZELTIQ AESTHETICS DERMAL COOLING DEVICE | Aug 24, 2010 | Unknown | Zeltiq Aesthetics |
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.